MAUDE Adverse Event Report: ST PAUL CADD SOLIS HPCA PUMPS - 2110; PUMP, INFUSION

Model Number 21-2111-0300-01

Device Problems Inaccurate Delivery (2339); Calibration Problem (2890)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the device needs calibration as it is over infusing.Not dispensing correctly.No patient injury/involvement reported.

Manufacturer Narrative

Other, other text: one device was received for evaluation.Visual inspection found the device to have a scratched lcd lens.There was no evidence to be found in the device's event history log.Three accuracy tests were performed.Upon review, the reported problem was unable to be duplicated.The service history review identified no indication that the complaint was related to a service of the device within the review period.D3, g1,g2 email is: (b)(4).

• Brand Name: CADD SOLIS HPCA PUMPS - 2110
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17213393
• MDR Text Key: 318143663
• Report Number: 3012307300-2023-06761
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-2111-0300-01
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1